Oncology Drug Reference Sheet: Erdafitinib

September 24, 2019 by Erin Dickman DNP, RN, OCN®

Erdafitinib (Balversa™) is the first targeted therapy that the U.S. Food and Drug Administration (FDA) approved for treatment of metastatic bladder cancer. 

It received accelerated approval (https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-metastatic-bladder-cancer) in April 2019 based on tumor response rate results from a phase II, multicenter, open-label, single-arm study in 87 patients with disease that had progressed on or after at least one prior chemotherapy and that had at least one of the following genetic alterations: FGFR3 gene mutations (R248C, S249C, G370C, Y373C) or FGFR gene fusions (FGFR3-TACC3, FGFR3-BAIAP2L1, FGFR2-BICC1, FGFR2-CASP7), as determined by a clinical trial assay. The results demonstrated a 32.2% objective response rate as assessed by a blinded independent review committee. Responders included patients who had previously not responded (https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-metastatic-bladder-cancer) to anti-PD-L1/PD-1 therapy.


Targeted therapy/fibroblast growth factor receptor (FGFR) kinase inhibitor 


Erdafitinib is indicated for treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has susceptible FGFR3 or FGFR2 genetic alterations and progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy (http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/BALVERSA-pi.pdf).

Select patients for therapy based on an FDA-approved companion diagnostic for erdafitinib, which looks for evidence of a susceptible FGFR3 or FGFR2 mutation or gene fusion within the tumor specimen.

Dosing and Administration

Erdafitinib’s recommended starting dose is 8 mg (two 4 mg tablets) orally once daily, with a dose increase to 9 mg (three 3 mg tablets) once daily based on serum phosphate levels and tolerability at 14–21 days. Swallow tablets once daily whole with or without food. If vomiting occurs any time after taking erdafitinib, do not take an additional dose; continue with the planned dose the next day. Treatment should continue until disease progression or unacceptable toxicity occurs (http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/BALVERSA-pi.pdf)

Adverse Reactions

The most common adverse reactions (http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/BALVERSA-pi.pdf) (≥ 20%) were increased phosphate, stomatitis, fatigue, increased creatinine, diarrhea, dry mouth, onycholysis, increased alanine aminotransferase, increased alkaline phosphatase, decreased sodium, decreased appetite, decreased albumin, dysgeusia, decreased hemoglobin, dry skin, increased aspartate aminotransferase, decreased magnesium, dry eyes, alopecia, palmar-plantar erythrodysesthesia syndrome, constipation, decreased phosphate, abdominal pain, increased calcium, nausea, and musculoskeletal pain.

Nursing Considerations

Erdafitinib can cause fetal harm. Complete a pregnancy test prior to starting therapy. Advise patients of the potential risk to the fetus and to use effective contraception

Patient Education 

Gero-Oncology Considerations

No clinically meaningful trends in the pharmacokinetics of erdafitinib were observed based on age (21–88 years), sex, race, or body weight (36–132 kg).

Safe Handling

Erdafitinib is considered a hazardous drug because of its reproductive risk of embryo-fetal toxicity. Women of childbearing potential should inform providers of a known or suspected pregancy and have a pregnancy test before beginning treatment. Men and women must use effective contraception during treatment and for one month following the last dose. Women receiving erdafitinib should not breastfeed their children during treatment and for one month after their last dose.  

Patient Assistance Programs

For patient support for erdafitinib, call 877-757-0667 or visit JanssenPrescriptionAssistance.com (http://www.janssenprescriptionassistance.com/).

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